GAC’ Transition plan and transition timeline for new ISO 15189:2022
Overview and Significance:
ISO 15189:2012 is the international standard for the medical laboratories — Requirements for quality and competence and has been updated and revised. The new edition was released in December 2022.
As per ILAC a three-year transition period will be allowed for accredited laboratories to transition to the 2022 version of ISO 15189.
While both the 2012 and 2022 edition of ISO 15189 will remain valid during the three-year transition period, please refer to the ILAC GA resolution below:
ILAC Resolution GA 26.08
As the revised version of ISO 15189 is scheduled for publication in 2022 or early 2023, the General Assembly endorses the recommendation of the AIC that a transition period of 3 years from the date of publication be adopted.
Noting that the requirements for Point of Care Testing (POCT) contained in ISO 22870:2016 have been incorporated into the revised ISO 15189, ISO 22870:2016 in conjunction with ISO 15189:2012 will still be recognized as a Level 4 standard for POCT for the duration of the transition period.
At the end of the transition period, accreditation of a medical laboratory to ISO 15189:2012 and accreditation of POCT to ISO 22870:2016 in conjunction with ISO 15189:2012 will not be recognized under the ILAC Arrangement.
The implementation of this transition period for ISO 15189:2022 by the signatories to the ILAC MRA for the accreditation of medical laboratories will be monitored by the ILAC AMC to ensure the deadline is achieved. The process used by the AMC to monitor this implementation of the revised standard will be similar to that used during the implementation of ISO/IEC 17025:2017
Following the above timelines and guidance GAC requires that all its existing accredited medical laboratories are smoothly transitioned to the newer version of ISO 15189 before the GAC set deadline i.e., 30th June 2025, in this regard all the upcoming due assessment should be conducted following the new edition of ISO 15189:2022.
As of 1st October 2023, GAC is no longer accepting applications under the previous version of the ISO 15189:2012, while GAC is now accepting the applications under the newly published standard ISO 15189:2022.